New York, NY: The Food and Drug Administration (FDA) has said it is investigating some 775 reports of serious side effects associated with 50 over-the-counter (OTC) children's medicines made by McNeil, a division of Johnson & Johnson, which were recalled earlier this month due to quality and safety issues. Among the adverse events are reports of seven deaths since May 1, when the recall was issued.
McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc, in consultation with the FDA, recalled all lots that have not yet expired of certain OTC Children's and Infants' liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait. The recall was prompted by drug manufacturing deficiencies, according to a recent statement by the FDA.
The products under recall include certain liquid infant's and children's Tylenol®, Motrin®, Zyrtec®, and Benadryl® products. A complete list of products and lot numbers can be found here.
Some of the products included in the recall may contain a higher concentration of active ingredient than specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, FDA advises consumers who have purchased these recalled products to discontinue use.
April 30-10: McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants' and Children's Products [FDA: PRESS ANNOUNCEMENTS]
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Last updated on May-26-10 |
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